Recall of Prazosin Hydrochloride Capsules Due to Impurity Concerns
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Appco Pharma LLC is recalling 88,008 bottles of Prazosin Hydrochloride Capsules because of detected impurities exceeding acceptable limits, affecting nationwide distribution in the United States.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 14, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Appco Pharma LLC is recalling Prazosin Hydrochloride Capsules due to a cGMP deviation involving the detection of Nitrosamine Drug Substance-Related Impurities, specifically N-nitroso-prazosin impurity C (NNP), above acceptable limits.
Which Products Are Affected
The affected products are Prazosin Hydrochloride Capsules, USP, 1mg, in 100-count bottles. The product is manufactured for Biocon Pharma Inc. and by Appco Pharma LLC. National Drug Codes (NDCs) include 70377-066, 70377-067, 70377-068, and package NDC 70377-066-11. A total of 88,008 bottles are affected, with the following lots: 2404160C (Exp. 2026/MAR), 2406253C (Exp. 2026/MAY), 2407311C (Exp. 2026/JUL), 2407312C (Exp. 2026/JUL), 2408350C (Exp. 2026/JUL), 2505172C (Exp. 2027/MAY), and 2506191C (Exp. 2027/JUN). The recall involves nationwide distribution in the United States.
What You Should Do
Consumers who have the affected products should contact the recalling firm, Appco Pharma LLC, for instructions on returns or refunds. The recall was initiated via e-mail, and further details can be obtained from the firm at their address: 262 Old New Brunswick Rd Ste N, Piscataway, NJ 08854-3888.
Why This Matters
This recall highlights potential risks associated with drug impurities that could affect patient safety, impacting over 88,000 bottles of a prescription medication distributed across the United States.
Source
This information is from the FDA recall notice with recall number D-0419-2026. For more details, visit the FDA website at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts or search for the recall using the event ID 98658.
Original source: FDA Official Notice ↗
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