Alyacen 7/7/7 Recall Issued for Impurity Issues
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Glenmark Pharmaceuticals Inc. is recalling specific lots of Alyacen 7/7/7 tablets due to out-of-specification total impurities.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Glenmark Pharmaceuticals Inc., USA initiated a voluntary recall due to failed impurities/degradation specifications after out-of-specification results for total impurities were identified.
Which Products Are Affected
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.035mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only. NDC 68462-556-29. Affected lots: 20240411 (Exp: 6/30/2026) and 20250252 (Exp: 3/31/2027). Distributed nationwide in the United States.
What You Should Do
Consumers should contact their healthcare provider or pharmacist regarding the recalled product. The recall was initiated via letter.
Why This Matters
This Class II recall affects prescription contraceptive tablets distributed across the United States.
Source
FDA recall D-0588-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (933 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.